Phase 1
N=50
Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
Glaucoma, Open-Angle · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01215786 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcome: Primary: Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 — 25.98; 26.58; 26.45; 25.93 Millimeters of mercury (mm Hg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo) (Drug); timolol ophthalmic solution 0.5% (Drug); AGN-207281 vehicle ophthalmic solution (Placebo) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 |
25.98; 26.58; 26.45; 25.93; 26.61; 26.30 | — |
| SECONDARY Mean Concentration of AGN-207281 in Plasma at Day 7 |
177 | — |
| SECONDARY Mean Concentration of AGN-207281 in Plasma at Day 14 |
540 | — |
Summary
This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.
Eligibility Criteria
Inclusion Criteria
- Ocular hypertension or primary open-angle glaucoma in each eye
- Requires IOP-lowering therapy in both eyes
- Visual acuity score of 20/100 or better in each eye
Exclusion Criteria
- Experienced significant weight change (over 10 pounds) within 60 days
- History of alcohol or drug addiction
- History of migraines or frequent headaches
- Anticipated wearing of contact lenses during the study
- Required chronic use of ocular medications during study
- Eye surgery within 6 months
- Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months
- Use of oral, intramuscular, intravenous corticosteroids within 21 days
- Use of ophthalmic corticosteroids within 2 months
Data sourced from ClinicalTrials.gov (NCT01215786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.